This invention relates specifically to multi-functional “sharps” containers which provide (i) safe transportation of the container and a large number, i.e., a “bulk” quantity of unused pen needle assemblies (sometimes hereafter referred to as “PNAs”) therein, (ii) the safe sequential dispensing of the aforesaid unused PNAs from the container and (iii) the safe sequential feeding or insertion of used PNAs into the container for safe storage therein.
Because of well known health issues, the safe disposal of medical and other syringes has long been a high priority for the related professions and industries. The prior art containers for such syringes are commonly termed “sharps” containers and many configurations of these are found in public venues such as hospitals, medical clinics, and retail establishments. These containers are usually securely attached to some base means and have a lock means to permit controlled and safe disposal of used “sharps.”
There are also prior art “portable” sharps containers for syringes. Examples of prior art portable “sharps” containers for syringes are U.S. Pat. No. 5,494,158 and U.S. Pat. No. 6,685,017; these sharps containers necessarily are large because of the elongated length of the syringes.
Medical delivery pens have, more recently, become widely used instead of or in addition to syringes, e.g., by diabetics, who frequently inject themselves several times a day with accurately measured, adjustable amounts of insulin or other medication. Medical delivery pens include a reservoir of medication and a distal end adapted to be attached (usually by thread means) to a pen needle assembly. As is well known (see, for example FIG. 1 of U.S. Pat. No. 5,545,145), the pen needle assembly has (within an outer, generally cylindrical shield 28) a generally cylindrical housing 26 within which is mounted an axially extending hollow needle 21, (i) the proximal end 24 of which punctures a seal in the distal end 16 of the medical delivery pen 10 (to allow the flow there-through of medication) when the delivery pen is screwed into the proximal end of the pen needle cylindrical housing 26, and (ii) the distal end 22 of which is for insertion into tissue of the person requiring the medication. The pen needle assemblies typically include a removable thin sterile seal covering the proximal (large diameter) end of the said outer shield and a removable tube-like shield covering the distal portion of the hollow needle. The assembled pen needle assembly is then factory sterilized. The user of a pen needle assembly removes the seal from the outer shield, screws the pen into the proximal end of the pen needle housing, removes the outer and tube-like shields, sets the medical delivery pen for the desired dose of medication, and then inserts the distal end of the pen needle into the target tissue following which the medical delivery pen is actuated to deliver the desired dose of medication through the hollow needle into said tissue.
Many diabetics routinely administer medication to themselves several times a day by injection of a pre-selected quantity of insulin (or medical substitute medication) in liquid form; the correct amount of medication can be determined from prior professional medical instruction or by use of convenient blood analysis kits which are small, compact and provide rapid indicators of the user's blood sugar level. The several daily injections are, at least in part, done away from the diabetic's home or residence which has made the use of medical delivery pens widespread. The aforesaid testing kits and the medical delivery pens are relatively small in size and can easily fit within a woman's purse or equivalent. A typical scenario for a diabetic at a restaurant is, before a meal, to use the blood sugar testing kit to obtain an indicator of his or her blood sugar level. This information then facilitates programming or adjusting the medical delivery pen to deliver the desired quantity of medication. Then the pen with an attached PNA (sans the outer protective shield) is used to inject the medication. These steps require a relatively short length of time and can be done with minimum loss of privacy.
In a perfect world, the user of a pen needle assembly would, after the first use of a pen needle assembly, carefully detach the used pen needle assembly from the medical delivery pen and safely dispose said assembly. The approved procedure is (i) insertion of the distal end of the needle into the tube-like shield, NS (sometimes omitted) and thence the shielded needle and cylindrical housing into the outer shield, (ii) unscrewing of the medical delivery pen from the proximal end of the pen needle cylindrical housing, and (iii) careful placement of the used pen needle assembly into a safe sharps container. Alas, the recommended procedure is not always followed. Used (and potentially dangerous) pen needles, with or without outer shields, are routinely left in unsafe places where third parties may unwittingly be “stuck.” Examples of such unsafe places are purses, the seat pockets on the back of aircraft seats, private and public wastebaskets, garbage cans, dumpsters and empty milk or other unsafe containers.
One prior art example of a container for unused and used pen needle assemblies is U.S. Pat. No. 5,545,145 which shows a tube containing a small number of unused pen needle assemblies arranged in axial alignment. This patent also teaches that, as unused assemblies are removed from one end of the tube, then a used assembly may be inserted into the tube from the other end. The tube is adapted to be attached to the side of a medical delivery pen. This arrangement has significant shortcomings. The capacity is quite limited and, potentially dangerous “sticks” could occur when a user tries to insert a used assembly (with or without the protective outer shield) into the used end of the tube.